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Enforcement of FDA: crash course in the area of drug, biologic, and device law. identify major statutory enforcement authority under the Food, Drug, and Cosmetic

Enforcement of FDA:

crash course in the area of drug, biologic, and device law.

identify major statutory enforcement authority under the Food, Drug, and Cosmetic Act (e.g., seizures, injunctions, criminal prosecution)

administrative mechanisms available to the FDA (e.g., Warning Letters, inspections and Form 483s, adverse publicity, and recalls).

identify what other federal agencies or actors must be involved in the enforcement activities.

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